In the disclosure of the present invention reference is mostly made to the treatment of diabetes by delivery of insulin, however, this is only an exemplary use of the present invention.
Drug delivery devices for delivering a drug such as insulin to a patient are well known and generally comprise a reservoir adapted to contain a liquid drug, a pump assembly for expelling a drug out of the reservoir to the patient. Such devices are often termed infusion pumps and are normally provided with a user interface allowing a user to control the operation of the pump. The user interface provided on some of the first pumps allowed the user to change a basal infusion rate and program a bolus infusion of a desired size. More recent infusion pumps have provided a number of more advanced features such as a number of basal rates to choose among, temporal basal, bolus calculations based on blood glucose (BG) input and/or meal size, diary functions, food data bases, connectivity to external devices, e.g. BG meter (BGM), PC, PDA or mobile phone.
An infusion pump may basically be a remotely controlled implantable pump or an external pump carried outside the human body and connected thereto by a transcutaneous access device such as a soft cannula or a needle. The external pump may be a traditional durable pump adapted to e.g. be worn in a belt at the waist of the user, this allowing the user to operate the pump by directly accessing the user interface on the pump, e.g. in order to change infusion rate or to program a bolus infusion. However, the pump may also be worn hidden under clothing this making operation more difficult. Correspondingly, it has been proposed to provide an infusion pump of the durable type with a wireless remote controller allowing the user to access some or all of the functionality of the pump, see for example U.S. Pat. No. 6,551,276, US 2005/0022274 and US 2003/0065308, which are hereby incorporated by reference, the latter disclosing an ambulatory medical device (MD) adapted to receive control messages from a communication device (CD).
As traditional durable external pumps are relatively expensive it has been proposed to pro-vide disposable pumps which may be attached directly to the skin of the user by means of an adhesive at a lower surface of such a device. A disposable pump may be provided to the user prefilled or it may be adapted to be filled by the user. Correspondingly, the pump may be a unitary fully disposable device or it may comprise two or more portions adapted to be used for different periods of time. Thus, for a skin-mountable device, typically comprising an adhesive allowing the device to be attached directly to the skin of the user, a remote controller would appear even more desirable as it would reduce the cost of providing a full user interface on the pump. Correspondingly, EP 1 177 802 and U.S. Pat. No. 6,740,059, which are hereby incorporated by reference, disclose semi-disposable and fully disposable infusion devices (which may be termed a local device or unit) which are intended to be operated primarily or entirely by a wireless remote controller (which may be termed a remote device or unit). As the delivery device thus does not have to be provided with a user interface such as a display and keyboard, the semi-disposable or disposable infusion can be provided more cost-effectively.
A drug delivery system, either as a unitary device or as a system comprising e.g. a drug de-livery pump and a remote controller, or adapted to communicate with external units, e.g. a PDA or PC, may be provided with a diary function allowing data to be stored, either automatically or by the user. For example, a drug delivery system may be store infusion data such as bolus and temporal basal, blood glucose data such BG values and other data such as meal size and medicine taken. EP 1 494 158 discloses a system and method for managing presentation of medical data, involving presenting medical data, e.g. BG values, downloaded from a device in selected graphical display charts in visual display. US 2005/0022274 discloses a drug delivery system comprising a remote controller with a memory and display allowing the user to store and retrieve data, e.g. BG values which can be displayed either as values or as a graph for one or more days. When travelling across time zones, it may be desirable to change the time setting, however, this may result in problems displaying information graphically which has a time-stamp related to a given time setting, i.e. when there is a “gap” or an “overlap” in the diary. In this context time-setting being the management of the underlying time base, and time stamping being the memorialisation of some event or event stream as an evidentiary process. For example, when a person is in New York his/her BG meter (when provided with a clock function) will show the local time correctly only if the meters time-setting has been set corresponding to the local time. If the person then performs a BG measurement the BG value can be stored together with a time-stamp indicating when the value was determined, the time-stamp being related to the actual time-setting.
Having regard to the above, it is the object of the present invention to provide a user inter-face and manner of presentation, as well as methods of operation, which assure one or more of the following: ease of retrieving stored data, easy to learn, intuitive and easy to use, fast to use, ease of entering data, ease of navigating. It is a further object to provide a user interface including enhanced display/patient notification features, safety features, and/or medical device programming/communication features. It is a yet further object to provide a user interface which reducing the likelihood that graphically displayed information is misinterpreted in case of a time change event.